NCT01473355已完成不适用
An Open, Prospective, Multi-center Study to Evaluate OsseoSpeed™ TX Single Implant 3 mm Diameter in the Anterior Mandible. A 3-years Follow-up Study.
Dentsply Sirona Implants and Consumables3 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Number of Survived Implants
研究概览
简要总结
The purpose of this study is to investigate the clinical efficacy of OsseoSpeed™ TX 3mm diameter implant in a Chinese population by evaluation of marginal bone level alteration, implant stability and implant survival in the posterior mandible up to 3 years after loading. Hypothesis: Early loading of the 3 mm implant is a safe and predictable procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent
- •Aged 20-75 years at enrolment
- •History of edentulism in the study area of at least two months
- •Presence of natural teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crowns
- •Deemed by the investigator to have a bone height and width suitable for 3.0 mm diameter study implant
- •Deemed by the investigator as likely to present an initially stable implant situation
排除标准
- •Unlikely to be able to comply with study procedures, as judged by the investigator
- •Uncontrolled pathologic processes in the oral cavity
- •Known or suspected current malignancy
- •History of radiation therapy in the head and neck region
- •History of chemotherapy within 5 years prior to surgery
- •Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration, as deemed by the investigator
- •Uncontrolled diabetes mellitus
- •Corticosteroids or any other medication that could influence post-operative healing and/or osseointegration
- •Smoking more than 10 cigarettes per day
- •Present alcohol and/or drug abuse
- •Involvement in the planning and conduct of the study (applies to both Astra Tech staff and staff at the study site)
- •Previous enrollment in the present study
- •Simultaneous participation in another clinical study, or participation in a clinical study during the last weeks prior to enrollment
研究组 & 干预措施
OsseoSpeed™ TX
Experimental
OsseoSpeed™ TX narrow implants (diameter 3 mm) in lengths of 11-15 mm
干预措施: OsseoSpeed™ TX (Device)
结局指标
主要结局
Number of Survived Implants
时间窗: Measured at the 3 year follow-up after implant loading.
Implant survival rate evaluated by clinically and radiographically counting the number of implants remaining in function
次要结局
- Number of Stable Implants(Measured at the 3 year follow-up after implant loading.)
- Evaluation of the Periimplant Mucosa Condition - By Assessment of PPD(Measured at the 3 year follow-up after implant loading.)
- Evaluation of the Periimplant Mucosa Condition - By Assessment of BoP(Measured at the 3 year follow-up after implant loading.)
- Presence of Plaque(Measured at the 3 year follow-up after implant loading.)
- Marginal Bone Level Alteration(Measured at the 3 year follow-up after implant loading.)
研究者
研究点 (3)
Loading locations...
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